James Hartten Arent Fox PLLC01.11.07
Democratic Control of Congress Sure to Impact Device Industry
James Hartten
Arent Fox PLLC
Now that the Democratic Party has taken control of both houses of Congress, the chairmanship of every House and Senate committee will change over to Democratic control when the 110th Congress convenes in January.
Based on early statements from incoming Democrats likely to chair Congressional committees influential in FDA matters, it appears that Democrats are poised to recommend that the agency modify a number of its regulatory policies, such as taking a stronger stance on enforcement activities, expanding post-market surveillance of FDA-regulated products and re-examining FDA regulation of single-use medical devices. Democrats also are interested in extending the agency’s medical device user fee program, as well as possibly reconsidering a number of recent FDA policy decisions, such as the recent decision to expand the number of women eligible to receive breast implants.
The members of the House of Representatives who will likely chair committees influential in the FDA oversight include Rep. John Dingell (D-MI), who likely will become chairman of the House Energy and Commerce Committee; Rep. Henry Waxman (D-CA), who is poised to become chairman of the House Government Reform Committee; and Rep. Rosa DeLauro (D-CT), who likely will be chairman of the House Appropriations subcommittee that oversees the FDA’s budget.
In the Senate, Sen. Edward Kennedy (D-MA), a longtime public health advocate, is expected to become chairman of the Senate Health, Education, Labor and Pensions Committee. As discussed below, each of these members of Congress plans to focus significant attention on the agency’s recent regulatory and enforcement policies and determine whether changes should be implemented to better facilitate the safe use of FDA-regulated products.
Possible Changes
Rep. DeLauro already has stated that she plans to conduct oversight of FDA policies involving both drugs and medical devices, including issues related to post-market surveillance of approved products, and the regulation of single-use devices. In addition, DeLauro may take a closer look at the FDA’s recent decision to expand the marketing of breast implants to a larger population of women to determine if women are adequately protected under the new policy. DeLauro also has stated that the agency’s budget should be increased to allow the FDA to expand its regulatory efforts to better ensure that its regulated products are safe, and that the public is adequately informed about any health effects that may be associated with product use. While this may sound like an altruistic goal, such initiatives often end up doing little more than increasing the regulatory burden on industry.
Rep. Dingell also can be expected to increase Congress’ regulatory oversight of the FDA, particularly with regards to post-market surveillance. A number of Democrats in Congress are still concerned about the well-publicized withdrawal by Merck of its prescription drug Vioxx in September 2004, and whether the FDA was slow to act in addressing the cardiovascular health risks associated with use of the product. Further, Dingell is committed to reauthorizing medical device user fees in 2007, which have risen in cost considerably since enactment of the Medical Device User Fee and Modernization Act of 2002. While the device industry is hoping to convince Congress to reduce medical device user fees, it may prove difficult to do so.
Rep. Waxman also is interested in increasing funding for the FDA so the agency can improve its oversight of the industry, particularly in the area of enforcement. In July 2006, Waxman released a report critical of the decrease in the number of warning letters issued by the FDA over the past few years. The decrease (by approximately 65%) in warning letters issued to companies generally is believed to be due to enactment of an internal FDA policy by former FDA General Counsel Daniel Troy, a Bush Administration appointee, that requires all warning letters to be reviewed by the FDA’s Office of General Counsel prior to issuance. In sum, Waxman likely believes that the FDA has been letting too many companies “off the hook,” as opposed to finding the policy successful in limiting FDA enforcement in cases involving minor infractions of the law.
The Kennedy Effect
In the Senate, Sen. Kennedy (D-MA), the current ranking minority member of the Committee on Health, Education and Pensions, is set to resume chairmanship of the committee, which is responsible for biomedical research and development, as well as conducting oversight of the FDA. On Dec. 7, Kennedy joined both Democrats and Republicans in a full Senate vote to approve Bush Administration nominee Andrew von Eschenbach, MD as FDA commissioner. The vote was 80-11 in favor of approval.
Bipartisanship aside, Kennedy has been critical of the FDA’s policy regarding conflict of interest waivers afforded to FDA advisory panel members. Such panels are regularly convened to vote on whether to recommend FDA approval of certain new drugs and medical devices subject to pre-market approval. Making it more difficult to obtain such a waiver also would make it more difficult for industry-affiliated medical professionals to sit on advisory panels. Other FDA issues of concern to Kennedy include expanding federal funding of embryonic stem cell research and improving Medicare’s prescription drug benefit. While passage of these measures could benefit the industry, both would require funding that may be hard to obtain given the current federal budget crunch.
Another factor that may contribute to a reduction in Republican influence on the Senate Health, Education, Labor and Pensions Committee is the retirement of Sen. Bill Frist (R-TN) outgoing Senate Majority Leader, and Mike DeWine (R-OH), who lost his re-election bid. Such a Republican leadership vacuum, coupled with Democrats seizing the majority of Committee seats, will make it all the easier for Kennedy to push his reform agenda. Meanwhile, certain members of the medical device industry hope the Democrats taking control of Congress will prove positive. For example, the National Electric Manufacturers Association and the Access to Medical Imaging Coalition are currently lobbying Congress to impose a two-year freeze on cuts to Medicare payments for certain imaging services that are currently imposed by the 2005 Deficit Reduction Act. The two groups likely will find Democrats more sympathetic to maintaining imaging coverage under Medicare, though the federal deficit will continue to influence Congressional spending decisions over the coming year.
Industry groups such as AdvaMed and the Medical Device Manufacturers Association recently stated that they can work effectively with the new Congressional leadership to promote industry goals. Indeed, both organizations expect to be active in 2007 educating new members of Congress on issues of concern to the device industry. Further, a number of congressman and senators expected to be influential in overseeing FDA policy (eg, Kennedy, Waxman) come from states such as Massachusetts and California that are home to numerous medical device manufacturers. Thus, they will be reluctant to support any legislative measures particularly adverse to the device industry.
In summary, it is clear that Democratic control of Congress will result in at least some changes taking place at FDA. Moreover, to the extent the 110th Congress can achieve its policy goals without increasing the burden on industry, a productive working relationship between industry and Congress will remain a realistic goal. However, if the Democrats attempt to overreach in their efforts to reform FDA, the industry may be forced to lobby President Bush to use his veto power to thwart any unreasonable initiatives, as it will be difficult for Democrats to muster a two-thirds vote in both Houses necessary to override a presidential veto. Thus, Democrats likely will need to temper their reform ambitions to build bipartisan support for their agenda and legislative initiatives.